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PregnanTech's LIONESS™, a disposable silicone vaginal device designed to prevent preterm birth by mechanically supporting the cervix, has undergone successful preclinical trials and a Phase 1 clinical safety and feasibility study in pregnant women at high risk for preterm birth, with results showing a high rate of term births and no significant device-related side effects[5][4]. A pivotal study in the US is planned for 2025.
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